Intragastric device for treating morbid obesity

ABSTRACT

The invention concerns an intragastric device inserted by endoscopic path into a patient&#39;s stomach ( 2 ) pertaining to a device assembly ( 1 ) comprising each a balloon or envelope ( 3 ) having a specific nominal volume sealingly connected to connecting means consisting of a disc ( 6 ) forming a support base for the balloon ( 3 ) against the inner wall of the stomach ( 2 ), a flexible tube or catheter ( 7 ) for connecting the balloon ( 3 ) to a filling device ( 4, 5 ), and catching means ( 9 ) integral with the tube or catheter ( 7 ), said connection means enabling to set and/or remove the balloon ( 3 ), and to fix either inside the patient&#39;s body or subcutaneously the filling ( 4, 5 ), to be able to bring the balloon or envelope ( 3 ) to its predetermined nominal volume.

[0001] The present invention relates to an intragastric device which isintroduced by an endoscopy procedure and permits treatment of patientssuffering from morbid obesity.

[0002] Devices for treatment of morbid obesity are known which consistof a ring which is positioned surgically around the cardiac part of thestomach in order to limit the amount of food absorbed.

[0003] The positioning of this type of device involves surgicaloperations which impose a burden on the patient.

[0004] In addition, this device has certain disadvantages because manyproblems or surgical complications arise after the use of this treatmenttechnique.

[0005] The U.S. Pat. No. 5,259,399 has disclosed a device with anelastic balloon which is introduced into the stomach from the outside byway of a permanent trocar fixed on the patient so as to empty into thestomach.

[0006] The device with an elastic balloon of variable volume comprisesmeans for rendering it leaktight and fixing it on the trocar in order toprevent any external escape from the stomach.

[0007] It is noted that this device has certain disadvantages as regardsits effectiveness in the treatment of morbid obesity.

[0008] The use of a rigid trocar is a major handicap for the patientbecause it prevents movements of various tissues and muscles, resultingin pain or discomfort for the patient.

[0009] In addition, the elastic balloon of variable volume can beinflated until occlusion of the patient's stomach, which entails a majorrisk.

[0010] The balloon of variable volume, on account of its elasticity, andwhen it is not inflated to its maximum volume, is not able to oppose thevolume of food ingested.

[0011] This is because the passage of the food leads to a deformation ofthe elastic balloon.

[0012] The intragastric device according to the present invention iseasily introduced by an endoscopy procedure which can be performed underlocal or general anesthesia by gastroenterologists or surgeons.

[0013] Thus, the intragastric device according to the present inventionis made up of a set of devices each comprising a balloon or envelope ofdefined nominal volume.

[0014] Thus, the object of the intragastric device according to theinvention is to fill a volume by way of a balloon of defined nominalvolume which is inflated inside the stomach.

[0015] With the intragastric device according to the present invention,it is possible to reduce the volume of the stomach, and hence the amountingested to give the patient a feeling of fullness, without any of thepsychological or physiological trauma associated with a strict diet.

[0016] Moreover, the balloon of the intragastric device according to thepresent invention is retained against the inner wall of the stomach,affording the patient comfort and avoiding possible migrations orblocking of the digestive tract.

[0017] The intragastric device according to the present invention,introduced by an endoscopy procedure into the stomach of a patient fortreating morbid obesity, is made up of a set of devices each comprisinga balloon or envelope of defined nominal volume which is connected in aleaktight manner to connection means consisting of a disk forming asupport base for the balloon against the inner wall of the stomach, aflexible tube or catheter for connecting the balloon to a supply device,and securing means integral with the tube or catheter, said connectionmeans making it possible, on the one hand, to position and/or recoverthe balloon and, on the other hand, to fix the supply device eitheroutside the patient's body or subcutaneously, in order to be able tobring the balloon or envelope to its defined nominal volume.

[0018] The intragastric device according to the present inventioncomprises a disk which is positioned about the flexible tube or catheterand against the outer wall of the balloon or envelope.

[0019] The intragastric device according to the present inventioncomprises a balloon which is fixed about the tube or catheter so thatthe latter opens out inside said balloon.

[0020] The intragastric device according to the present inventioncomprises securing means which consist of a joining piece of conicalprofile integral with a filament.

[0021] The intragastric device according to the present inventioncomprises a joining piece having a stub which penetrates inside aninternal bore of the tube or catheter.

[0022] The intragastric device according to the present inventioncomprises a filament having a straight or looped profile.

[0023] The intragastric device according to the present inventioncomprises a disk which is of circular shape.

[0024] The intragastric device according to the present inventioncomprises a disk which is of oval shape.

[0025] The intragastric device according to the present inventioncomprises a balloon or envelope which has an oval profile or otherprofile which is symmetrical with respect to the horizontal axis of thetube or catheter.

[0026] The intragastric device according to the present inventioncomprises a balloon or envelope which has an oval profile or otherprofile which is asymmetrical with respect to the horizontal axis of thetube or catheter.

[0027] The intragastric device according to the present inventioncomprises a balloon or envelope which has a kidney-bean-shaped profilesymmetrical with respect to the horizontal axis of the tube or catheter.

[0028] The intragastric device according to the present inventioncomprises a balloon or envelope which has a kidney-bean-shaped profileasymmetrical with respect to the horizontal axis of the tube orcatheter.

[0029] The following description in which reference is made to theattached drawings, which are given as nonlimiting examples, will permita better understanding of the invention, its characteristics, and itsadvantages.

[0030]FIG. 1 is a view illustrating the intragastric device according tothe present invention.

[0031]FIG. 2 is a view according to F in FIG. 1, showing the shape ofthe disk supporting the intragastric device according to the presentinvention.

[0032]FIG. 3 is a view showing a supply device of the nonreturn valvetype which is fixed on the flexible tube or catheter of the intragastricdevice according to the present invention.

[0033]FIG. 4 is a view showing another feed device of the implantablechamber type which is fixed on the flexible tube or catheter of theintragastric device according to the present invention.

[0034]FIG. 5 is a view showing a variant of the balloon or envelope ofthe intragastric device according to the present invention.

[0035]FIG. 6 is a view showing another variant of the balloon orenvelope of the intragastric device according to the present invention.

[0036]FIG. 7 is a diagrammatic view illustrating the positioning, on thepatient, of the intragastric device integral with the feed device of thenonreturn valve type.

[0037]FIG. 8 is a diagrammatic view showing the positioning, on thepatient, of the intragastric device integral with the feed device of theimplantable chamber type.

[0038] In FIGS. 1 and 2, an intragastric device 1 has been shown whichis implanted in the stomach 2 of a patient, and of which the shape andnominal volume of a balloon or envelope 3 is defined and permits thetreatment of a patient suffering from morbid obesity.

[0039] Each intragastric device is made up of a set of devices eachcomprising a balloon or envelope 3 of defined nominal volume of between100 cubic centimeters and 1100 cubic centimeters.

[0040] The intragastric device 1 comprises a balloon or envelope 3 ofoval or other shape whose defined nominal volume is obtained by thequantity of liquid or gas injected into it.

[0041] The intragastric device 1 comprises connection means making itpossible, on the one hand, to position and/or recover the balloon orenvelope 3 and, on the other hand, to fix a supply device 4, 5 eitheroutside the patient's body or subcutaneously, in order to be able tobring the balloon or envelope 3 to its defined nominal volume.

[0042] The connection means consist of a disk 6 forming a support basefor the balloon or envelope 3 against the inner wall of the stomach 2,and of a hollow tube or catheter 7 which is flexible for connection to asupply device 4, 5.

[0043] The balloon or envelope 3 has an oval profile or other profilewhich is symmetrical with respect to the horizontal axis of the flexibletube or catheter 7.

[0044] In one variant, the balloon or envelope 3 can have an ovalprofile or other profile which is asymmetrical with respect to thehorizontal axis of the flexible tube or catheter 7.

[0045] The tube or catheter 7 comprises securing means 9 which arearranged at the opposite end from the disk 6.

[0046] The disk 6 and the tube or catheter 7 are made from the sameplastic material such as polyurethane or silicone or the like.

[0047] In a nonlimiting manner, the disk 6 has either a circular shapeor an oval shape extending perpendicular about the outer periphery ofthe tube or catheter 7.

[0048] The disk 6 is positioned about the tube or catheter 7 in such away as to define a cylindrical bearing surface 10 of small dimensionconstituting a support on the inner wall of the stomach.

[0049] The disk 6 is positioned about the flexible tube or catheter 7and against the outer wall of the balloon or envelope 3.

[0050] The disk 6 is designed in such a way as to be able to undergoelastic deformation so as to press flat against the inner wall of thestomach 2 during introduction of the intragastric device 1.

[0051] The securing means 9 consist of a joining piece 11 of conicalprofile integral with a stub 12 which penetrates inside the internalbore 13 of the flexible tube or catheter 7.

[0052] The conical profile of the joining piece 11 is intended tofacilitate the dilation of the tissues, in order to withdraw the tube orcatheter 7 outside the stomach 2 and the abdominal wall.

[0053] In the continuation of its conical profile, the joining piece 11is integral with a filament 8 which can be straight or looped.

[0054] In FIG. 5, the intragastric device 1 according to the presentinvention has been shown comprising a balloon or envelope 3 whose outershape has a kidney-bean profile which is symmetrical with respect to thehorizontal axis of the flexible tube or catheter 7.

[0055] This particular profile of the balloon or envelope 3 permits,when the latter is brought to its defined nominal volume, a betteradaptation to the inner contour of the patient's stomach 2.

[0056] In FIG. 6, the intragastric device 1 according to the presentinvention has been shown in which the balloon or envelope 3 has akidney-bean-shaped outer profile which is asymmetrical with respect tothe horizontal axis of the flexible tube or catheter 7.

[0057] Specifically, it will be noted that the balloon or envelope 3 ofkidney-bean shape has, above the horizontal axis of the tube or catheter7, a part whose volume is greater than the part situated below said tubeor catheter.

[0058] The asymmetrical profile of the balloon or envelope 3 in relationto the horizontal axis of the tube or catheter 7 allows the latter toadapt to the inner profile of the stomach 2.

[0059] In FIG. 7, the intragastric device 1 has been shown inside thestomach 2 of a patient. This device is put in place by an endoscopyprocedure, passing it through the mouth and then the esophagus 14 andpositioning it in the stomach 2.

[0060] The operating surgeon proceeds to recover the tube or catheter 7percutaneously by virtue of the securing means 9 with which it ispossible to spread the tissues apart without tearing them.

[0061] The tube or catheter 7 is fixed by an attachment system 15 to theskin of the patient's belly in order to hold the intragastric device 1in place.

[0062] The tube or catheter 7 is then cut outside the patient's body toremove the joining piece 11 integral with the filament 8 constitutingthe securing means 9, and to permit fitting of a supply device 4 withnonreturn valve.

[0063] The balloon or envelope 3 is inflated by way of a syringe or thelike (not shown) which is fitted onto the supply device 4 in order tobring said balloon or envelope to its defined nominal volume.

[0064] Once the defined nominal volume of the balloon 3 is reached, thelatter is pressed flat against the inner wall of the stomach 2, by meansof external traction on the tube or catheter 7, so as to ensure, byvirtue of the disk 6, perfect leaktightness between the stomach 2 andthe peritoneal cavity.

[0065] In FIG. 8, the intragastric device 1 has been shown inside thestomach 2 of a patient. This device is put in place by an endoscopyprocedure, passing it through the mouth and then the esophagus 14 andpositioning it in the stomach 2.

[0066] The operating surgeon proceeds to recover the tube or catheter 7percutaneously by virtue of the securing means 9 with which it ispossible to spread the tissues apart without tearing them.

[0067] The tube or catheter 7 is fixed by an aponeurotic attachmentsystem which holds the intragastric device 1 in place.

[0068] The tube or catheter 7 is then cut to remove the joining piece 11integral with the filament 8, in order to permit the fitting of a supplydevice of the implantable chamber type 5 which is positionedsubcutaneously.

[0069] The balloon or envelope 3 is brought to its defined nominalvolume by way of a Huber needle associated with a syringe (not shown)which is introduced into the implantable chamber 5, available on themarket, for example, under the name “Districath”.

[0070] Once the defined nominal volume of the balloon or envelope 3 isreached, the latter is pressed flat against the inner wall of thestomach 2, by means of external traction on the tube or catheter 7, soas to ensure, by virtue of the disk 6, perfect leaktightness between thestomach 2 and the peritoneal cavity.

[0071] It will be noted that the effect of the intragastric device 1 isto reduce the volume of the stomach 2 and hence the amount ingested togive the patient a feeling of fullness.

[0072] It will be noted that the intragastric device 1 does not requireany surgical intervention imposing a burden on the patient and causingtrauma.

[0073] It will be noted that the intragastric device 1 can be easilyremoved at the end of treatment on account of its external orsubcutaneous fixation.

[0074] It will be noted that the defined nominal volume of each balloonor envelope 3 of a set of intragastric devices 1 will never obstruct themaximum volume of the stomach, so as to avoid any occlusion of thelatter and thereby safeguard the patient.

[0075] It must also be understood that the above description has beengiven only by way of example and that it does not in any way limit thescope of the invention, and that the details described could be replacedby any other equivalent means without thereby departing from said scopeof the invention.

1. An intragastric device introduced by an endoscopy procedure into thestomach (2) of a patient for treating morbid obesity, characterized inthat it is made up of a set of devices (1) each comprising a balloon orenvelope (3) of defined nominal volume which is connected in a leaktightmanner to connection means consisting of a disk (6) forming a supportbase for the balloon (3) against the inner wall of the stomach (2), aflexible tube or catheter (7) for connecting the balloon (3) to a supplydevice (4, 5), and securing means (9) integral with the tube or catheter(7), said connection means making it possible, on the one hand, toposition and/or recover the balloon (3) and, on the other hand, to fixthe supply device (4, 5) either outside the patient's body orsubcutaneously, in order to be able to bring the balloon or envelope (3)to its defined nominal volume.
 2. The intragastric device as claimed inclaim 1, characterized in that the disk (6) is positioned about the tubeor catheter (7) and against the outer wall of the balloon or envelope(3).
 3. The intragastric device as claimed in claim 2, characterized inthat the balloon or envelope (3) is fixed about the tube or catheter (7)so that the latter opens out inside said balloon.
 4. The intragastricdevice as claimed in claim 1, characterized in that the securing means(9) consist of a joining piece (11) of conical profile integral with afilament (8).
 5. The intragastric device as claimed in claim 4,characterized in that the joining piece (11) has a stub (12) whichpenetrates inside an internal bore (13) of the tube or catheter (7). 6.The intragastric device as claimed in claim 4, characterized in that thefilament (8) has a straight or looped profile.
 7. The intragastricdevice as claimed in claim 1, characterized in that the disk (6) is ofcircular shape.
 8. The intragastric device as claimed in claim 1,characterized in that the disk (6) is of oval shape.
 9. The intragastricdevice as claimed in claim 1, characterized in that the balloon orenvelope (3) has an oval profile or other profile which is symmetricalwith respect to the horizontal axis of the tube or catheter (7).
 10. Theintragastric device as claimed in claim 1, characterized in that theballoon or envelope (3) has an oval profile or other profile which isasymmetrical with respect to the horizontal axis of the tube or catheter(7).
 11. The intragastric device as claimed in claim 1, characterized inthat the balloon or envelope (3) has a kidney-bean-shaped profilesymmetrical with respect to the horizontal axis of the tube or catheter(7).
 12. The intragastric device as claimed in claim 1, characterized inthat the balloon or envelope (3) has a kidney-bean-shaped profileasymmetrical with respect to the horizontal axis of the tube or catheter(7).